Adjustable extension compression posterior spinal orthosis and method

ABSTRACT

A spinal orthosis and method of applying extension and compression forces onto a user spine includes a lumbo-sacral compression unit conforming to a portion of a user&#39;s torso and exerting an encircling compressive force to provide a hydraulic lift. A posterior spinal frame member is secured by the lumbo-sacral compression unit to be cantilevered upward along the user&#39;s spine. A pair of adjustable shoulder strap assemblies are connected to an upper portion of the posterior spinal frame member and adjacent a lower portion of the posterior spinal frame member to enable a user to adjustably apply a thoracic force with adjustable controlled buckles and straps positioned on the user&#39;s chest.

RELATED APPLICATION

The present application is a continuation application from applicationSer. No. 12/670,847 filed on Jan. 26, 2010 which is a §371 applicationof PCT/US07/74875 filed on Jul. 31, 2007, now U.S. Pat. No. 8,066,654.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention is directed to a lightweight brace or ortho praxisdevice and method for the treatment of patients with upper back pain,strain, osteoporosis and compression fractures and more particularly, toan easily worn and adjusted extension compression posterior spinalorthosis for applying extension and compressions forces in the treatmentof spinal disorders.

2. Description of Related Art

Problems related with spinal disorders have been a bane of mankind,probably from the time that man started walking on two legs. Numerousdifferent attempts have been made to provide an orthotic treatment torelieve pain and compensate for various types of spinal disorders suchas multiple compression fractures that may occur from osteoporosis andkythotic postural changes.

Frequently, these spinal braces have employed a triangular or threepoint force vector system that includes an anchor point centrallylocated across the chest of the user which can be provided by a sternalpad supported, for example, by a metal frame and a corresponding anchorpoint on the lower portion of the abdomen, provided by a pubic padsupported by a frame. Thus, two forward pressure points are provided onthe front of the user and a centrally located adjustable lumbar pad isprovided on the user's back, again adjustably fixed to a metal frame sothat three force vectors can be applied to create a condition ofhyperextension on the spinal column, while permitting some mobility tothe user. An example can be seen in the Jewett brace shown in U.S. Pat.No. 3,274,996.

Basically, this orthotic modality of treatment involves an anteriorspinal hyperextension orthosis to create spaced anterior anchorstabilization points across the sternum and pubic areas with anadjustable force applied at an intermediate position on the user's back.Numerous variations of this treatment can be found, for example in U.S.Pat. No. 5,599,287, U.S. Pat. No. 6,190,343, U.S. Pat. No. 6,790,191,U.S. Pat. No. 6,010,472, U.S. Pat. No. 5,674,187, and U.S. Pat. No.3,945,376. Other examples and variations can also be found in theorthodesic art.

An article in the American Journal of Physical Medicine andRehabilitation “Effects of a New Spinal Orthosis of Posture, TrunkStrength And Quality of Life In Women With Postmenopausal Osteoporosis,”Volume 83, No. 3, Pages 177-186, March 2004, described a study on themanagement of vertebra fractures caused by osteoporosis. A thoracolumbarorthosis disclosed in the study included a narrow back pad centeredalong the spine which could be workable as cold material to adjust tothe particular patient, a system of belts, and an abdominal pad to applylower, intermediate and upper forces on the back pad to mold it to thespinal region of the user. See U.S. Pat. No. 6,063,047. Also see U.S.Pat. No. 2,828,737.

There is still a need in the orthopedic field to provide a lightweight,comfortably wearing extension compression orthosis and method to treatmid spinal pathologies that does not require cumbersome strappingarrangements. Such a brace should be easily adjusted by the user toaccommodate for various daily activity demands, to provide an improved,firm, lightweight posterior support structure that permits vector forcesto be adjustably applied to the body by the user and to permitadjustments in the length of the orthosis to match the size andconfiguration of the user.

SUMMARY OF THE INVENTION

The present invention provides a lightweight spinal orthosis such as anadjustable extension compression posterior spinal brace that can beeasily placed on the user's body while permitting the user to controland easily change how much extension and compression is desired fordifferent daily activities of the user during the wearing of the spinalorthosis.

The present invention further provides a posterior spinal frame memberthat can be firmly anchored without requiring cumbersome sternum andpubic pads to facilitate a method of treatment.

The present invention permits a patient that may be in pain and in afrail condition because of age and/or postoperative circumstances, todon such a spinal orthosis and to remove it in a relatively easy manner.

The spinal orthosis can be easily adjusted by the user to thereby permitthe user to accommodate different daily activities and to encourage theuser to consistently use and receive the benefit of the spinal orthosisthroughout the day. Thus, the present invention encourages usercompliance while removing unsightly anterior sternum and pubic pads, andenables the spinal orthosis to be worn beneath clothing to relieve anyuneasiness experienced by the user in his/her appearance in the public.

The spinal orthosis includes a lumbo-sacral compression unitincorporating a first body member conforming to a portion of the user'storso, a second body member conforming to another portion of the user'storso, and a closure unit, operatively connected to the first and secondbody members, for creating a compressive force about the user's torso,for example about the waist of the user, with a minimum of user effort.The closure unit provides a mechanical advantage so that a light forceapplied by the user can create significant encircling compression forcesto create a hydraulic lift with corresponding beneficial effects to thespinal column and also firmly anchoring a posterior spinal frame memberalong the user's spine while distributing the compressive force aroundthe entire waist of the user.

The spinal frame member can have an elongated triangular configurationwith lateral semi-rigid plates extending outward from a rigid spinalframe member, which further has appropriate openings to minimize weightwhile maintaining a rigid configuration. The lateral semi-rigid platescan be bendable by the lumbo-sacral compression unit to firmly anchorthe spinal frame member on the user's waist, when the compression forceis distributed across the lower portion of the spinal frame member. Thelateral semi-rigid plates are thin enough to eventually conform to thewaist of the user after repeated applications of a compressive forceduring use.

Alternatively, the spinal frame member can be integrally formed, byplastic molding, with relatively movable lateral portions, for examplein plastic with living hinges provided for connection between the curvedlateral portions and a rigid spinal frame members to readily enablecompliance with the shape of the user and a firm spreading of thecompressive forces from the first and second body members.

A pair of adjustable shoulder strap assemblies are connected to an upperportion of the spinal frame member and also connected adjacent a lowerportion of the spinal frame member, wherein the user can adjustablyalter the position of the shoulder straps during use to optimize theextension of the shoulders and the upper back of the user.

Each one of the adjustable shoulder straps can include a first strapunit with a shoulder pad, adjustably connected to the upper portion ofthe spinal frame member, and a second strap unit also adjustablyconnected to the first strap unit and to the lower portion of the spinalframe member. The first strap unit can include a friction buckle memberwith the second strap unit including a strap connected to the lowerportion of the spinal frame member and extending through the frictionbuckle member whereby the user can pull the extended straps downward onthe sides of the chest for adjusting extension of the shoulder and upperback of the user, and can easily loosen the straps by relative movementof the buckle and pulling the strap forward away from the chest. Thus,by lifting a tab on the buckle, it is capable of releasing the tensionand the buckle can be slid upward to provide less force and also anadequate opening for removing the orthosis.

Likewise, the lumbo-sacral compression unit can employ a tab or D-shapedring which in combination with a hook and nap material such as Velcro™permits an easy release of the encircling compression forces. Thus,during daily activities, relative adjustments applied by thelumbo-sacral compression unit and the shoulder strap assemblies can beeasily accomplished by the user while wearing the spinal orthosis.

An orthotist can adjust the spinal frame member to the specific size andshape of the user and can also increase the length of the spinal framewith an adjustable extension in one embodiment.

The adjustable extension compression posterior spinal orthosis of thepresent invention can address, among other problems, ThoracicCompression Fractures, Kyphosis, Osteoporosis, Upper thoracic spinestrain due to postural problems, and acute pain that can be relieved bythoracic extension.

The adjustable extension compression posterior spinal orthosis canextend the user's thoracic spine and unweight any wedged vertebral bodyin order to promote healing and pain relief. Our spinal appliancestabilizes the pelvis and lumbar spine with the compression beltcomponent. The compression belt also serves as an anchor for thecantilevered posterior component. This anchor is more secure than theorthoses which are only strap based and do not have a level of pelviccompression. Also, the patient experiences a unique combination ofpelvic and lumbar spine compression and stabilization along with thethoracic extension due to the custom contoured posterior cantileveredbeam with shoulder straps to apply the thoracic extension load. Unique,anti-twist straps also make for a very simple don/doff that is similarto a backpack or jacket. The compression belt panels are also suspendedwith elastic straps so they can be held in just the right position toallow for simple don/doff without requiring the patient to reach behindand twist to find the panels.

BRIEF DESCRIPTION OF THE DRAWINGS

The objects and features of the present invention, which are believed tobe novel, are set forth with particularity in the appended claims. Thepresent invention, both as to its organization and manner of operation,together with further objects and advantages, may best be understood byreference to the following description, taken in connection with theaccompanying drawings.

FIG. 1 is a front perspective view of the extension compressionposterior spine orthosis of the present invention;

FIG. 2 is an exploded perspective view of FIG. 1;

FIG. 3 is a cross-sectional view taken along line 3-3 of FIG. 2;

FIG. 4 is an elevated rear view of the present invention;

FIG. 5 is a rear view with a partial cutaway of the closure unit;

FIG. 6 is an opposite side view from FIG. 5 of the closure unit;

FIG. 7 is an exploded view of a two part elastic band;

FIG. 8 is an exploded view of an adjustable spinal frame;

FIG. 9 is an assembled elevated rear view of the spinal frame of FIG. 8;

FIG. 10 is a modified spinal extension member;

FIG. 11 is a schematic illustration of initially applying the extensioncompression spinal orthosis on a user; and

FIG. 12 is a schematic illustration of a user adjusting the thoracicextension force.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made in detail to the preferred embodiments of theinvention which set forth the best modes contemplated to carry out theinvention, examples of which are illustrated in the accompanyingdrawings. While the invention will be described in conjunction with thepreferred embodiments, it will be understood that they are not intendedto limit the invention to these embodiments. On the contrary, theinvention is intended to cover alternatives, modifications andequivalents, which may be included within the spirit and scope of theinvention as defined by the appended claims. Furthermore, in thefollowing detailed description of the present invention, numerousspecific details are set forth in order to provide a thoroughunderstanding of the present invention. However, it will be obvious toone of ordinary skill in the art that the present invention may bepracticed without these specific details. In other instances, well knownmethods, procedures, components, and materials have not been describedin detail as not to unnecessarily obscure aspects of the presentinvention.

Referring to FIG. 1, an anterior frontal view of a extension compressionspinal orthosis 2 of the present invention is disclosed in a manner thatwould be initially operatively positioned on a user or patient. Theactual position on the user is not completely to scale and will vary,depending on the height, weight and body configuration of the user.Usually a doctor or an orthotist will initially adjust thepre-fabricated spinal orthosis to fit the user.

A lumbo-sacral compression unit 3 permits a user to provide compressiveforces about his/her torso by simply pulling and removably fastening afastener member 4 to a surface portion of the orthosis. The appliedforce can be distributed evenly about the lower torso or waist of theuser and creates a hydraulic lift effect to help relieve pressure on thespinal column.

As can be seen in FIGS. 5 and 6, a closure unit 6 mounted on the rearposterior side, as shown in FIG. 2, can include a first connector member8 and a second connector member 10. A first body member 12 and a secondbody member 14 are capable of conforming to a portion of the user'storso, such as the waist of the user. Preferably, the first body member12 and the second body member 14 are made with a porous material such asan extra firm polyester from Gehring Textiles, Inc. of Garden City, N.Y.and nylon webbing to enable ventilation of the user's body through therespective body members 12 and 14.

Alternatively, stiffening support members (not shown) can be insertedinto or on the respective body members 12 and 14, including, ifnecessary, an abdominal stay member, not shown. Such stay members can beinserted, for example, within pockets provided in the respective bodymembers, or could be appended, for example, with a hook and nap materialsuch as Velcro™ for appropriate location relative to the user on theinterior surfaces of one or more body members. Thus, the basic spinalorthosis 2, shown in FIG. 1 can be customized with accessory parts tomeet specific medical demands of a particular patient.

As shown in FIG. 1, the lumbo-sacral orthosis 2 has basically a widebelt-like configuration of approximately six inches in height thatgradually increases to a posterior portion of approximately eight inchesin height, although other dimensions can be used depending on thephysical characteristics of the particular user, and the desire toprovide a hydraulic lift. As can be seen in FIG. 4, the respectiveposterior ends have a nap material 16 on an exterior side of the firstbody member 12, and a nap material 18 on an exterior side of the secondbody member 14.

Additionally, an elongated rectangular strip or panel of nap material 20is provided on the exterior of the first body member 12, and a similarelongated panel of nap material 22 is provided on the exterior of thesecond body member 14, as shown in FIG. 4. These respective strip orpanel members 20 and 22 provide anchor points for a corresponding hookmaterial 54, attached to the fastener member 4. The fastener member 4 asshown can be a plastic D ring that can be attached to a flexibleelongated cord 30.

The cord 30 can be formed from a nylon material having an exteriorbraided surface to thereby provide a low friction but strong pullmaterial, such as Dacron cord with a diameter of 0.042 inches and a 90pound test strength.

Additional elongated strips or panels of nap material are also utilizedon an interior surface, that is interior relative to being adjacent to auser's body. Thus, the first body member 12 has a strip of nap material24 and the second body member 14 has a strip of nap material 26. Thesestrips will be subsequently described in correlation with a posteriorspinal frame member 56, as shown in FIG. 2.

A distal end of the first body member 12 has a semicircular patch of napmaterial 32 on the exterior surface. A distal interior surface of thesecond body member 14 has a patch of a semicircular configuration ofhook material 34. Thus, these respective distal ends of the first andsecond body members, can be subjectively fastened about the waist of auser and they collectively form a fastener unit 58 to connect the firstbody member 12 to the second body member 14, on the front or anteriorsurface of the user.

Referring to FIGS. 5 and 6, the closure unit 6 includes fastenerportions 36 on an underside of a hook material on the first connectormember 8 and fastener portions of a hook material 38 on the secondconnector member 10. The respective hook members can be subjectivelypositioned to removably connect with the exterior nap material 18 on thesecond body member 14, and the nap material 16 on the exterior surfaceof the first body member 12.

As can be readily appreciated, the first connector member 8 and thesecond connector member 10 could alternatively be permanently fastenedby rivets or stitching or otherwise to their respective body members.

The respective connector members 8 and 10 can be formed from a fabricmaterial. However, alternative embodiments such as a plastic housing,which would either be permanently fastened or removably fastened on therespective body members can be used. The advantage of having hook andnap material permits subjective adjustment for both location and size ofthe user by the orthotist and also permits the closure unit to beremoved so that the first body member 12 and the second body member 14can be separately washed and cleaned, if necessary.

In FIGS. 5 and 6, the upper surface of the connector members 8 and 10can include open support pockets 40 and 42 of a nylon webbing that cancover and house a plurality of plastic support posts 44 and loopmaterial to which a lower base is sewn. The support posts 44 will extendperpendicular to an exterior surface of the user, when the first bodymember 12 and the second member 14 are appropriately fastened about theuser. The support posts 44 can be formed, for example, of extrudedplastic or alternatively can be arranged to be individual metal rivetsbetween a pair of plates forming a housing for the support posts 44.

In the embodiment shown, the support posts 44 are respectively affixedto a base member 46. Each of the pockets 40 and 42 have an open slit topermit the cord member 30 to wrap around the respective support posts 44in each of the connector members 8 and 10 to thereby provide amechanical advantage or force multiplier when the cord 30 is pulled overthe posts 44 by the user. As can be seen, the fastener member 4 isattached, for example, through the strip of hook material 54, directlyto each end of the unitary cord 30. Because both ends of the cord 30 arerespectively pulled, the distance of movement of the fastener member 4about the waist of the user can be shortened while providing the desiredhydraulic lift.

As can be appreciated, one end of the cord 30 could, alternatively, beanchored to one of the connector members and the pulling of the free endby the fastener member 4 can produce the same mechanical advantage ofmultiplying the force exerted by the user for pulling the posterior endsof the first body member 12 and the second body member 14 together, tocreate the compressive hydraulic lifting force on the user. The term“hydraulic lifting force” refers to the squeeze or compression of thewaist of the user's body because of the flexible and fluid contents ofthe user's body. However, both ends of the cord 30 are preferablyconnected to the fastener member 4 to limit the hand movement of theuser about his/her body when compared with only pulling one end of thecord 30.

As shown in FIG. 5, a base member 48 and the first connector member 8can further have cord pull member guide eyelets 50 that permit therespective ends of the cord member 30 to be aligned so they can exitthrough ports 52 for attachment to the fastener member 4. One side ofthe fastener member 4, as shown in FIG. 6, includes a strip of hookmaterial 54. The rear of the exterior panels 16 and 18 on the respectivefirst body member 12 and second body member 14 shown in FIG. 4, permit aremovable locking of the closure unit 6 and a subjective alignment onthe respective body members 12 and 14 to meet the subjective demands ofthe individual user or patient. The user, after pulling upon thefastener member 4, can appropriately adhere the hook material strip 54to either one of the strips of nap material 22 or 20, to maintain theappropriate compressive force. Because of the mechanical advantage, auser could be relatively feeble and still exert a significantcompressive force with relatively little effort.

The ability of the cord 30 to slide with low friction across therespective support posts 44 provides a relatively compact and efficientmechanical advantage without requiring additional moving parts, such aspulleys. Alternatively, pulleys could be used in an alternativeembodiment if necessary The individual support posts 44 can comprise arivet assembly having either a sufficient smooth outer surface or thebody of the rivet can be mounted within a sleeve that is fixed andgauged by a rivet when it is attached to its appropriate base materialto extend perpendicularly upward. Preferably, an economically producedseries of posts and housing components can be manufactured from plastic.The nylon cord 30 having a low coefficient of friction can appropriatelyslide across the surface of the posts regardless of the material ofwhich it is made.

Referring to FIG. 3, the posterior spinal frame member 56 is formed froma lightweight material such as an aluminum alloy, and has an upper frameportion 60 and a lower frame portion 62. An orthotist can subjectivelybend the frame member 56 to adjust to the particular physiologicalcharacteristics of the patient.

The upper frame portion has side concave edges from a moderatelyenlarged upper end of about 3 inches in width. The upper end includesoblong slots of about 1⅛ inch in length for receiving 1 inch wide nylonweb straps as shown in FIG. 4, to be described subsequently. A series ofcircular holes of 1⅝ inches in diameter can be placed in the upper frameportion 60 to lower the weight.

As seen in FIGS. 2 and 3, a central outwardly curved channel of about 2inches in width and ½ inch in depth terminating in a 6¼ inch width isprovided on the upper frame portion to further add strength. The holes64 also facilitate the bending of the upper frame portion 60 by theorthotist to adjust the shape of the spinal frame number 56 to thepatient's spine. The curved channel of the upper frame portion 60accommodates a clearance to allow for vertebral prominence on elderlypatients. The upper and lower frame portions 66 and 62 provide anapproximately elongated U-shaped contact surface that is to be alignedon either side of a user's spinal column.

The lower frame portion 62 has a slight triangular configuration with acorresponding elongated central opening 66 terminating in a peaked lowerportion. The opening 66 gradually increases from 1½ inch in width at thetop to 2¼ inch in width at the bottom. The bottom frame portion 68 canbe bent away from the user to both prevent any body interference and toprovide some additional strength.

A pair of lateral semi-rigid plates 70 and 72 can be affixed to therespective sides of the lower frame portion 62, for example, by rivets.The plates can be formed of plastic and are capable of being conformedto the lower back of the user when the closure unit 6 exerts acompressive force through the first and second body members 12 and 14.The semi-rigid plates 70 and 72 progressively narrow in width at anintermediate concave position as each plate extends outward from thespinal frame member.

A cross-sectional view is shown in FIG. 3 with the rivets 74.Additionally, a rivet can also extend through the lower frame portion oneither side of the elongated opening 66 to affix flexible straps 76 and78, which form components in a pair of adjustable shoulder strapassemblies 80 and 82. A respective first strap 84 and 86 are eachjournaled in the oblong openings at the top of the spinal frame member56. A portion of each of the straps 84 and 86 are sewed onto a centralportion of the respective shoulder pads 88 and 90.

The lower portion of each of the first and second straps are looped andsewed to be anchored at a lower portion of the shoulder pads and tosecure the respective buckles 92 and 94 such as a Tri-Glide buckle fromHi Tex Corp. The upper end of the respective straps 76 and 78 are loopedthrough the buckles 92 and 94, and a free end of each of the respectivestraps 84 and 86 extend downward from the buckles so that the user canpull the strap to tighten the shoulder pads 88 and 90 across theshoulders of the user and thereby exert a force pushing the user's backand shoulders against the posterior spinal frame member 56. Lifting alower tab on the respective buckles 92 and 94 can release the frictiongrip on the respective straps 78 and 76 to permit an easy adjustment oftension forces and a further opening of the loop of the adjustableshoulder strap assemblies 80 and 82 can provide an enlarged opening forremoving the orthosis. Appropriate buckles 96 and 98 can permit furtheradjustment of the sizing of the first straps 84 and 86 and the free endof these straps can be appropriately retained, for example by a Velcro™adjustable loop members 100 and 102.

The Velcro™ strips 104 and 106 can be adhered to the sides of the bottomframe portion 68 and individual patches of Velcro™ hook strips 124 canbe placed between the holes 64 in the upper frame portion 60, with alsoa Velcro™ hook strip 122 on the bottom frame portion 68, to therebyadhere to a pad 108 configured to cover the posterior spinal framemember 56. A spinal frame member pad 108 has a nap surface which can beremovably attached to a hook material of a Velcro™ type. Supplementalfoam pads 110 and 112 have a configuration to match the respectivelateral semi-rigid plates 70 and 72. Adhesive straps can be used toattach the plate pads 110 and 112 directly to the respective semi-rigidplates 70 and 72.

As seen in FIG. 2, a square of nap material 114 and 116 is adheredrespectively to the semi-rigid plates 70 and 72. Straps 118 and 120 witha combination of nap and hook material can be connected respectively tothe square nap material patches 114 and 116 and can be bent to extendbehind the respective lateral semi-rigid plates 70 and 72. Preferably,the respective straps 118 and 120 are centered at the lower point of theconcave edges of the semi-rigid plates 70 and 72 so that the hookmaterial can fasten to the respective first body member 12 and thesecond body member 14 by interacting with the respective straps of napmaterial 24 and 26.

This arrangement provides a relatively movable interconnection of theposterior spinal frame member 56 to the first body member 12 and thesecond body member 14 in the lumbo-sacral compression unit 3. As aresult, when closure unit 6 is activated or released, the respectivefirst body member 12 and second body member 14 can extend towards oraway from each other and the posterior spinal frame member 56 wouldpermit such movement while still being appropriately aligned relative tothe lumbo-sacral orthosis compression unit 3.

Also, when the user removes the extension compression spinal orthosis 2,the mounted posterior spinal frame member 56 will maintain itsrelationship to the lumbo-sacral compression unit orthosis 3 and bepositioned for easy placement again onto the user.

The closure unit is shown in FIG. 5 with a flexible elastic band 28 toalso permit relative movement and to assist in preventing entanglementof foreign objects in the draw cord 30.

As an alternative embodiment, the elastic band 28 can actually be splitinto two separate small bands 28 a and 28 b having appropriate strips 27on each side edge of each of the respective elastic bands 28 a and 28 bwith nap material on one side and a hook material on the other side, seeFIG. 7. As shown in FIG. 6, the nap material is connected with the hookmaterial 27 and similar strips obscured by the respective firstconnector member and the second connector member can be inserted betweenthe connector members and the nap material respectively 16 and 18 asshown in FIG. 4 on the first body member 12 and the second body member14 and between the hook material 36 and 38.

In FIGS. 2 and 4, the elastic band material 28 a and 28 b are used todirectly close the gap between the respective ends of the first bodymember 12 and the second body member 14. As shown in FIG. 5, the elasticband 28 a can be positioned on the exterior side to cover the cord 30 toprevent it from being entangled with foreign objects.

As can be readily appreciated, pairs of elastic bands 28 a and 28 bcould encompass both the interior and exterior side of the cord 30between the first connector member 8 and the second connector member 10.

Referring to FIG. 2, an orthotist can appropriately size, and ifnecessary bend the posterior spinal frame member 56 to the particularneeds of the patient. Generally an orthotist will order a pre-fabricatedbrace by specifying a particular patient size such as large, small,etc., and then can adjust the brace to customize it for the particularpatient.

The pads 110 and 112, shown in FIG. 2, can be appropriately adhered bystrips of adhesive to the sides of the lateral semi-rigid plates 70 and72 while still permitting access to insert the straps 118 and 120 forconnection with the square nap material 116 and 118 on the respectivesemi-rigid plates 70 and 72. The spinal frame pad 108 can then beadhered to the strips of hook material 104 and 106, the rectangularpatch of hook material 122 and the small patches of hook material 124 onthe upper frame portion 60. The reverse side of the pad 108 has anappropriate cloth nap configuration that permits removable adherencewhile also permitting the pad 108 to be periodically washed for sanitarypurposes when it is removed.

The orthotist can also appropriately adjust the respective pair ofadjustable shoulder strap assemblies 80 and 82 and can cut the free endsof the first straps 84 and 86 to provide enough of an extension for theuser to grab and adjust for his/her body size. As can be appreciated, aD-shaped ring could also be attached to the end of the straps after theadjustment by the orthotist to further facilitate an easy adjustment bya user during daily activities. The orthotist will usually teach apatient how to lift the front tab of the respective buckles 94 and 92for releasing the free ends of the straps 76 and 78. The orthotist canalso adjust the shoulder pads 88 and 90. The first strap 84 and 86 withthe shoulder pads 90 and 88 can be appropriately connected to the upperportion 60 of the spinal frame member 56 for the particular patient.

The orthotist will also appropriate fit and adjust the lumbo-sacralorthosis 3 including in an embodiment where the closure unit 6 isremovable, the position of the first connector member 8 and the secondconnector member 10 on the respective nap material 16 and 18 at the rearof the first body member 12 an the second body member 14. Connecting thefirst and second body member 12, 14 with the closure unit 6 forms aunitary lumbo-sacral compression unit to extend around a user's torso.

Referring to FIG. 8, an adjustable spinal frame member 126 has aplurality of holes 132 and 134 in the lower portion of the spinal framecolumn 128 which can receive fasteners 136 such as screws, rivets andthe like for fixedly securing the base spinal frame column 128 and anadjustable lower spinal extension member 130 at an appropriate positionto match the length of a user's spine. Elongated slots 138 and 140 inthe spinal extension member 130 permit a relative alignment oradjustment to the length of the user's spine column by moving theextension member 130 along the spinal frame column 128.

The spinal extension member 130 can mount the lateral semi-rigid plates70 and 72 with appropriate rivets. Spinal extension member 130 can beformed from an aluminum plate or alternatively from a relatively rigidplastic plate.

As shown in FIG. 9, an adjustment, a, of the overall length of thespinal frame member 126 can be easily accomplished, thereby reducing therequirement of providing different pre-fabricated sizes to the orthotistand thus limiting the inventory requirements on the manufacturer.

FIG. 10 discloses a further modification of an integrated spinalextension member 142 that can be molded from plastic with a thicker andmore rigid central plate 144 when compared with thinner and flexiblelateral 146 and 148 connected to the central plate 144 by first livinghinges 150 and 152.

The living hinges 150 and 152 are formed integrally in the plasticmolding process by providing grooves of a narrow thickness that enablerelative movement of each lateral side plate 146, 148 relative to themore rigid central plate 144 to align the molecules of the plastic toenable while still held repetitive pivotal movements. The lateral plates146, 148 can further bend to conform to the user's waist and enable afurther distribution of the compression forces from the lumbo-sacralorthosis 3. By providing a series of parallel second living hinges 154in lateral side plate 146 and a series of parallel second living hinges156 in lateral side plate 148 the respective lateral side plates 146 and148 can easily conform to the user's waist size by bending relative tothe spinal column while still maintaining a significantly rigidconfiguration of longitudinal support. Additionally, the lateral sideplates 146 and 148 can be adjusted by cutting distal portions or edgesalong the living hinge grooves to adjust for the patient's waist size.

As can be appreciated by an orthotist, the extension compression spinalorthosis 2 of the present invention, can stably position the posteriorspinal frame member 56 so that it can be firmly aligned with the spineof the user. The lower frame portion 62 and the lateral semi-rigidplates 70 and 72 receive a compressive force from the lumbo-sacralorthosis 3 with concave end portions engaging the respective first bodymember 12 and the second body member 14, while providing an expandedapplication of force across the lower back of the user. At the sametime, the first body member 12 and the second body member 14 are stillrelatively movable for applying and releasing the compressive force, andthrough straps 118 and 120, maintain a relative relationship with theposterior spinal frame member 56, even when the lumbo-sacral orthosis 3is released and the extension compression spinal orthosis 2 is removedfrom the patient.

The compressive force of the lumbo-sacral orthosis 3 will be evenlydistributed around the waist of the user to both prevent a localizedapplication of a high force at one point on the user's waist and backand also to provide a hydraulic lift on the spinal column. The spinalframe member 56 is, accordingly, firmly anchored to be cantileveredupward along the spinal column from the user's waist.

Adjustment of the respective free ends of straps 76 and 78 on the lowersecond strap units can pull the shoulders of the user back against theupper portion of the spinal frame member 56. The user will not havesignificant constriction across his/her chest that would impairbreathing and can readily adjust the spinal orthosis 2 for example, toaccommodate sitting or other motions with relatively easy adjustments.Accordingly, our design encourages prolonged usage to ensure the userreceives the benefits of a remedial extension compression orthosis.

Additionally, the lumbo-sacral orthosis 3 can be easily disassembledfrom the extension compression spinal orthosis 2 and used independentlyas a functional lumbar spinal orthosis. The strap configuration of thisdesign also provides an anti-twist operation to assist users withlimited shoulder mobility. Likewise, our padded shoulder strap designcan loosen without completely unfastening in order to facilitate anuncomplicated reapplication to the user. The spinal frame member 56 ispreferably made from aluminum but other metals and a plastic molded orplastic composite frame could be used. A Cool Foam™ can be applied asremovable and washable pads to extend from the thoracic area to thesymphysis pubis.

Referring to FIG. 11, a schematic view of a user of the presentinvention, such as a patient suffering from osteoporosis with a bentspinal column has donned the extension compression spinal orthosis 2 ofthe present invention and has tightened the lumbo-sacral compressionunit 3 to enable the posterior spinal frame member 56 to be cantileveredupward along the user's spinal column. The adjustable shoulder strapassemblies 80 and 82 are loosely positioned across the user's shoulderswith an adjustable strap and buckle combination available on therespective right and left hand side of the chest of the user.

As shown, the user can grasp the free end of the strap 76 and 78extending through the respective buckles 94 and 92 and by pullingdownward as shown in FIG. 12, can extend the user's shoulder and upperback to contact the cantilever posterior spinal frame member 56. Thus, athoracic extension force can be applied to each of the shoulders of theuser to force the user's shoulders towards the posterior spinal frame 56and thereby extend the user's spinal column as shown in FIG. 12. Byreleasing the hold of the buckles, the straps can be loosened to adjustthe desired force for the user. As a result, the user experiences auniformly distributed compression force around his/her waist to assistin a hydraulic lift of his/her spinal column while at the same timeanchoring the posterior spinal frame member 56 to permit the shoulderpads 88 and 90 in the adjustable shoulder strap assemblies to exert arearward thoracic support for straightening the user's spine.

Accordingly, the extension compression spinal orthosis 2 of the presentinvention permits the user to directly apply appropriate extension andcompression forces to the user's spine with a wearable posterior spinalorthosis. The extension compression spinal orthosis 2 of the presentinvention is easily adjusted by the user to encourage extended use andcan be easily removed and reapplied. The user's arms are not encumberedby any apparatus pressing across his/her chest. The lumbo-sacralcompression unit 3 provides a mechanical advantage to exert an evendistribution of compression force about the waist of the user withminimal effort.

Those skilled in this art will appreciate that various adaptations andmodifications of the just-described preferred embodiments can beconfigured without departing from the scope and spirit of the invention.Therefore, it is to be understood that, within the scope of the amendedclaims, the invention may be practiced other than as specificallydescribed herein.

1. A spinal orthosis comprising: a lumbar-sacral compression unitincluding a first body member conforming to a portion of a user's torso,a second body member conforming to another portion of a user's torso,and a closure unit operatively connected to the first and second bodymembers for exerting a compressive force on the user's torso through thefirst and second body member; a posterior spinal frame member,configured to provide a remedial corrective shape for the user's spinalcolumn, has a lower portion secured by the lumbar-sacral compressionunit to enable positioning of the posterior spinal frame member, alongand offset at a distal end from the user's spine; and a pair ofadjustable shoulder strap assemblies extending from an upper portion ofthe posterior spinal frame member and supported adjacent to the lowerportion of the posterior spinal frame member wherein the user canadjustably apply a compression force about a waist portion of the torsowith the lumbar-sacral compression unit to initially fix the distal endof the posterior spaced frame offset from the user's spine and canadjust the pair of adjustable shoulder strap assemblies to extend theshoulders and upper back of the user towards the distal end of theposterior spinal frame member to align the user's spinal column into anorthopedic corrective position relative to the posterior spinal framemember.
 2. The spinal orthosis of claim 1 wherein the spinal framemember has a central oblong opening.
 3. The spinal orthosis of claim 1wherein a pair of spaced lateral semi-rigid plates extend outward fromthe posterior spinal frame member, the pair of lateral semi-rigid platesare bendable by the lumbar-sacral compression unit to anchor the lowerportion of the posterior spinal frame member on the user's waist.
 4. Thespinal orthosis of claim 3 wherein the semi-rigid plates are formed ofplastic.
 5. The spinal orthosis of claim 4 wherein distal ends of thesemi-rigid plates each have a concave shape.
 6. The spinal orthosis ofclaim 3 wherein the semi-rigid plates progressively narrow in width atan intermediate position, as each plate extends outward from the spinalframe member.
 7. The spinal orthosis of claim 1 wherein each adjustableshoulder strap assembly includes a shoulder pad extending from the upperportion of the spinal frame member and a strap unit adjustably connectedto the lower portion of the posterior spinal frame member.
 8. The spinalorthosis of claim 7 wherein each strap unit includes a friction bucklemember and a strap connected adjacent to the spinal frame member andextending through the friction buckle member whereby the user can pullthe strap for adjusting an extension of the shoulder and upper back ofthe user.
 9. The spinal orthosis of claim 1 wherein the closure unit hasa first connector member with a first plurality of support postsoperatively connected to the first body member, the first plurality ofsupport posts are fixed and have axes extending approximatelyperpendicular to the surface of the first body member, a secondconnector member with a second plurality of support posts operativelyconnected to the second body member, the second plurality of supportposts are fixed and have axes extending approximately perpendicular tothe surface of the second body member, and an elongated flexible pullmember operatively extending between the respective first and secondsupport posts to provide a mechanical force advantage when tightened bythe user in moving the first body member and second body member toconform about and against the user's torso.
 10. The spinal orthosis ofclaim 1 further including a spinal pad member removably connected to theposterior spinal frame member.
 11. The spinal orthosis of claim 10further including a plate pad member removably connected to eachrespective semi-rigid plate.
 12. The spinal orthosis of claim 11 whereineach adjustable shoulder strap assembly includes a strap and a shoulderpad extending from the upper portion of the spinal frame member of aconfiguration to extend across the user's shoulder and overlay a portionof the user's chest with the shoulder pad and a releasable buckle memberpositioned at a distal end of the strap, the strap is connected near thelower portion of the spine and extends through the releasable frictionbuckle member to enable the user to pull the strap to exert thoracicextension force to adjust an extension of the shoulder and upper back ofthe user as the user's spinal column is forced into a correctivealignment relative to the posterior spine frame member.
 13. A spinalorthosis comprising: a lumbar-sacral compression unit that is configuredto adjustably encircle a user's waist and includes an elongated flexiblepull member that can be fastened across a surface of the compressionunit to provide a mechanical force advantage for a user to distributecompression forces about a portion of the user's torso by tightening thepull member and fastening the pull member at a desired compressionforce; a posterior spinal frame member, having a lower positionoverlapped by the lumbar-sacral compression unit to fixedly secure theposterior spinal frame member, is of a configuration to be cantileveredupward from the user's waist to provide contact support at a positionoffset from the user's spinal vertebrae with an elongated surface thatterminates at a distal end offset from and adjacent the shoulders of theuser's upper back on an upper portion of the posterior spinal framemember; and a pair of adjustable shoulder strap assemblies extendingrespectively from an upper portion of the posterior spinal frame memberand a lower portion of the posterior spinal frame member whereby theuser can releasably adjust the pair of adjustable shoulder strapassemblies, from positions adjacent the user's chest, to extend theshoulder and upper back of the user posteriorly towards the fixedcantilevered posterior spinal frame member in an orthopedic correctiveposition for the user's spine.
 14. The spinal orthosis of claim 13wherein the posterior spinal frame member is a malleable metal member.15. The spinal orthosis of claim 13 wherein each adjustable shoulderstrap assembly includes a shoulder pad extending from the upper portionof the spinal frame member and a strap unit adjustably connected to theshoulder pad and adjacent the lower portion of the spinal frame member.16. The spinal orthosis of claim 13 wherein each strap unit includes afriction buckle member and a strap connected adjacent to the lowerportion of the spinal frame member and extending through the frictionbuckle member whereby the user can pull the strap for adjusting aposterior extension of the shoulder and upper back of the user to enablean orthopedic corrective position with the posterior spinal framemember.
 17. The spinal orthosis of claim 13 further including anadjustable control unit on each adjustable shoulder strap assembly forapplication of thoracic force by the user whereby the user can tightenand/or release thoracic shoulder forces.
 18. The spinal orthosis ofclaim 17 wherein the posterior spinal frame member is provided with acorrective curvilinear configuration to enable a correctivehyperextension of the user's spine when thoracic exterior forces areapplied to the user's shoulders.
 19. The spinal orthosis of claim 13wherein the posterior spine frame member is cantilevered upward andoffset from the user's spinal column to terminate at the rear of theuser's shoulders, the posterior spine frame member is configured into anorthopedic curved corrective position relative to the user's spinalcolumn whereby a thoracic extension force applied through the pair ofadjustable shoulder strap assemblies force the user's spinal column toalign with the orthopedic curved corrective position of the posteriorspine frame member.